DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendment filed 1/6/2026 is acknowledged.
Claims 1-3, 5-7, 11, 14, 16-21, 25, 26, and 28-30 remain pending in the current application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 5, 7, 14, 16-21, 25, 26, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Welch (US 20100016713 A1) in view of Caluser (US 20180046875 A1)
Regarding claim 1, Welch teaches a system for localizing an anatomical site of interest in a subject ([abst] stereotactic localization system for imaging a suspected cancer and guiding a physician in the removal of tissue samples for biopsy)
a grid localization system (GLS) ([0054] grid localization system 38)
a plurality of access regions for accessing the subject ([0053] Gamma guided stereotactic localization uses two gamma camera images of an object taken at different angles)
configured to identify from the plurality of access regions an access region of interest for accessing the anatomical site of interest wherein the indicator corresponds to an access region ([0054] The present invention is a fiducial marker that can be placed in the positioning system to render it visible to the gamma camera. The positioning system is placed adjacent to the object to be imaged and held rigidly in place. The location of the fiducial relative to the camera system is calculated from the gamma camera images. The location of the region-of-interest relative to the camera system is then calculated from the gamma camera images. The location of the region-of-interest relative to the fiducial marker can then be calculated. After the location of the region-of-interest relative to the fiducial marker is known, the positioning system can be used to accurately position and support any other hardware that needs to be positioned at the region-of-interest by measurements from the fiducial marker)
Welch fails to teach a plurality of light elements distributed along each horizontal row and each vertical row of the GLS, wherein each access region is represented by a light element on the horizontal row and a light element on the vertical row where the access region is located in the GLS; in communication with the GLS, a processor and a computer-readable medium comprising instructions that, when executed by the processor, causes the one or more light elements to identify from the plurality of access regions the access region of interest for accessing the anatomical site of interest by illuminating the light element on the horizontal row and the light element on the vertical row where the access region of interest is located in the GLS .
However, Caluser teaches a plurality of light elements distributed along each horizontal row and each vertical row of the GLS, wherein each access region is represented by a light element on the horizontal row and a light element on the vertical row where the access region is located in the GLS ([0048] A perspective view of surface frame 44 is illustrated in FIG. 6 and illustrates a grid 84 of visible lines, which can be incorporated in surface frame 44 to aid the localization of the surface landmarks 72, 74 detected with the camera system 48. In one embodiment, grid 84 is formed of intersecting light beams generated from a matrix of light sources 86, such as, for example laser emitting LEDS, which are integrated within the surface frame 44)
and wherein the GLS is in communication with a processor and a computer-readable medium comprising instructions that, when executed by the processor, causes the plurality of light elements to visually identify from the plurality of access regions the access region of interest for accessing the anatomical site of interest by illuminating the light element on the horizontal row and the light element on the vertical row where the access region of interest is located in the GLS ([0045] In one embodiment of the invention, camera processor 50 or processor 36, is programmed with one or more pattern recognition algorithms designed to process the acquired skin surface images and detect one or more surface landmarks 72, 74 located at the skin surface 46 within the surface frame 44. In an alternative embodiment, processor 36 of computer 34 may be programmed having one or more pattern recognition algorithms).
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Welch and Caluser are considered analogous because both disclose medical localization systems utilizing a grid. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use an LED based grid to perform the localization in order to coregister images with a higher degree of accuracy (Caluser [0007])
Regarding claim 5, Welch teaches an imaging unit configured to image the anatomy of the subject ([0054] the stereo imaging system 22)
Regarding claim 7, Welch teaches a plurality of quadrangular access regions and wherein the indicators are placed along the sides of the quadrangular access regions ([0019] FIG. 3 is a top view of a rectangular shaped fiducial source that can be inserted into the grid support structure depicted in FIG. 2).
Regarding claim 14, Welch teaches an adhesive on the side opposite to the side comprising the one or more indicators ([0059] grid localization plate 38 that is rigidly mounted above the object 32 to be imaged).
Regarding claim 16, Welch teaches an automated access device (AAD) that is in communication with the GLS and/or the processor, wherein the AAD, when actuated, accesses the anatomical site of interest based on the access region of interest or the depth of the anatomical site of interest as identified by the GLS or the processor ([0053] Once the location is correlated with the object, it can be used, for example, for positioning a needle)
Regarding claim 17, Welch teaches the AAD comprises one or more of: a hypodermal needle, vacuum-assisted device, obturator, and sensor ([0015] a biopsy needle)
Regarding claim 18, Welch teaches wherein the AAD, when actuated, obtains a biopsy sample from the anatomical site of interest ([0055] positioning a needle in a suspected tumor to collect a tissue sample for biopsy)
Regarding claim 19, Welch teaches the AAD, when actuated, obtains a breast or a prostate biopsy sample from the anatomical site of interest ([0064] The grid localization system 38 will also serve to stabilize the biopsy needle system during the gamma guided breast biopsy procedure)
Regarding claim 20, Welch teaches the AAD, when actuated, injects a compound to the anatomical site of interest ([0059] A marker source 46, shown in the end of the biopsy needle guide 44, can be inserted into the object 32 at the calculated location of the region of interest 42)
Regarding claim 21, Welch teaches A method of accessing an anatomical site of interest of a subject ([abst] stereotactic localization system for imaging a suspected cancer and guiding a physician in the removal of tissue samples for biopsy)
the method comprising placing the GLS at or near the anatomical site of interest of the subject ([0054] the positioning system can be used to accurately position and support any other hardware that needs to be positioned at the region-of-interest by measurements from the fiducial marker. A diagram depicting this concept is given in FIG. 1, showing the gamma guided stereotactic localization system 20 with grid localization system 38 and fiducial source 40, the gamma camera crystal 24, and the stereo imaging system 22. A top view of the grid localization system 38 with fiducial source 40 is shown in FIG. 2)
a plurality of access regions for accessing the subject ([0053] Gamma guided stereotactic localization uses two gamma camera images of an object taken at different angles)
configured to identify from the plurality of access regions an access region of interest for accessing the anatomical site of interest wherein the indicator corresponds to an access region ([0054] The present invention is a fiducial marker that can be placed in the positioning system to render it visible to the gamma camera. The positioning system is placed adjacent to the object to be imaged and held rigidly in place. The location of the fiducial relative to the camera system is calculated from the gamma camera images. The location of the region-of-interest relative to the camera system is then calculated from the gamma camera images. The location of the region-of-interest relative to the fiducial marker can then be calculated. After the location of the region-of-interest relative to the fiducial marker is known, the positioning system can be used to accurately position and support any other hardware that needs to be positioned at the region-of-interest by measurements from the fiducial marker)
and accessing the anatomical site of interest based on the access region of interest or the depth of the anatomical site of interest as identified by the GLS ([0054] the positioning system can be used to accurately position and support any other hardware that needs to be positioned at the region-of-interest by measurements from the fiducial marker. A diagram depicting this concept is given in FIG. 1, showing the gamma guided stereotactic localization system 20 with grid localization system 38 and fiducial source 40, the gamma camera crystal 24, and the stereo imaging system 22. A top view of the grid localization system 38 with fiducial source 40 is shown in FIG. 2)
Welch fails to teach a plurality of light elements distributed along each horizontal row and each vertical row of the GLS, wherein each access region is represented by a light element on the horizontal row and a light element on the vertical row where the access region is located in the GLS; in communication with the GLS, a processor and a computer-readable medium comprising instructions that, when executed by the processor, causes the one or more light elements to identify from the plurality of access regions the access region of interest for accessing the anatomical site of interest by illuminating the light element on the horizontal row and the light element on the vertical row where the access region of interest is located in the GLS .
However, Caluser teaches a plurality of light elements distributed along each horizontal row and each vertical row of the GLS, wherein each access region is represented by a light element on the horizontal row and a light element on the vertical row where the access region is located in the GLS ([0048] A perspective view of surface frame 44 is illustrated in FIG. 6 and illustrates a grid 84 of visible lines, which can be incorporated in surface frame 44 to aid the localization of the surface landmarks 72, 74 detected with the camera system 48. In one embodiment, grid 84 is formed of intersecting light beams generated from a matrix of light sources 86, such as, for example laser emitting LEDS, which are integrated within the surface frame 44)
and wherein the GLS is in communication with a processor and a computer-readable medium comprising instructions that, when executed by the processor, causes the plurality of light elements to visually identify from the plurality of access regions the access region of interest for accessing the anatomical site of interest by illuminating the light element on the horizontal row and the light element on the vertical row where the access region of interest is located in the GLS ([0045] In one embodiment of the invention, camera processor 50 or processor 36, is programmed with one or more pattern recognition algorithms designed to process the acquired skin surface images and detect one or more surface landmarks 72, 74 located at the skin surface 46 within the surface frame 44. In an alternative embodiment, processor 36 of computer 34 may be programmed having one or more pattern recognition algorithms).
Welch and Caluser are considered analogous because both disclose medical localization systems utilizing a grid. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use an LED based grid to perform the localization in order to coregister images with a higher degree of accuracy (Caluser [0007]).
Regarding claim 25, Welch teaches determine from a plurality of access regions in a GLS, the access region of interest for accessing an anatomical site of interest or a depth of the anatomical site of interest ([0054] The present invention is a fiducial marker that can be placed in the positioning system to render it visible to the gamma camera. The positioning system is placed adjacent to the object to be imaged and held rigidly in place. The location of the fiducial relative to the camera system is calculated from the gamma camera images. The location of the region-of-interest relative to the camera system is then calculated from the gamma camera images. The location of the region-of-interest relative to the fiducial marker can then be calculated. After the location of the region-of-interest relative to the fiducial marker is known, the positioning system can be used to accurately position and support any other hardware that needs to be positioned at the region-of-interest by measurements from the fiducial marker)
Welch fails to teach a plurality of light elements distributed along each horizontal row and each vertical row of the GLS, wherein each access region is represented by a light element on the horizontal row and a light element on the vertical row where the access region is located in the GLS; in communication with the GLS, a processor and a computer-readable medium comprising instructions that, when executed by the processor, causes the one or more light elements to identify from the plurality of access regions the access region of interest for accessing the anatomical site of interest by illuminating the light element on the horizontal row and the light element on the vertical row where the access region of interest is located in the GLS .
However, Caluser teaches a plurality of light elements distributed along each horizontal row and each vertical row of the GLS, wherein each access region is represented by a light element on the horizontal row and a light element on the vertical row where the access region is located in the GLS ([0048] A perspective view of surface frame 44 is illustrated in FIG. 6 and illustrates a grid 84 of visible lines, which can be incorporated in surface frame 44 to aid the localization of the surface landmarks 72, 74 detected with the camera system 48. In one embodiment, grid 84 is formed of intersecting light beams generated from a matrix of light sources 86, such as, for example laser emitting LEDS, which are integrated within the surface frame 44)
and wherein the GLS is in communication with a processor and a computer-readable medium comprising instructions that, when executed by the processor, causes the plurality of light elements to visually identify from the plurality of access regions the access region of interest for accessing the anatomical site of interest by illuminating the light element on the horizontal row and the light element on the vertical row where the access region of interest is located in the GLS ([0045] In one embodiment of the invention, camera processor 50 or processor 36, is programmed with one or more pattern recognition algorithms designed to process the acquired skin surface images and detect one or more surface landmarks 72, 74 located at the skin surface 46 within the surface frame 44. In an alternative embodiment, processor 36 of computer 34 may be programmed having one or more pattern recognition algorithms).
Welch and Caluser are considered analogous because both disclose medical localization systems utilizing a grid. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use an LED based grid to perform the localization in order to coregister images with a higher degree of accuracy (Caluser [0007])
Regarding claim 26, Welch teaches transmit to the GLS the information about the access region of interest for accessing the anatomical site of interest or the depth of the anatomical site of interest ([0064] The grid localization system 38 is used to locate the area of the breast or other body part that is directly above the suspected lesion. The grid 54 will be correlated with the location of the lesion that has been determined during the localization procedure via the fiducial marker 40. The fiducial marker 40 is imaged at the same time as the lesion and the location of the lesion relative to the fiducial marker 40 is calculated. The grid localization system 38 will also serve to stabilize the biopsy needle system during the gamma guided breast biopsy procedure).
Regarding claim 29, Welch fails to teach the plurality of light elements visually identify from the plurality of access regions the access region of interest for accessing the anatomical site of interest by further illuminating other light elements located around the access region of interest in addition to the light element on the horizontal row and the light element on the vertical row where access region of interest is located in the GLS.
However, Caluser teaches the plurality of light elements visually identify from the plurality of access regions the access region of interest for accessing the anatomical site of interest by further illuminating other light elements located around the access region of interest in addition to the light element on the horizontal row and the light element on the vertical row where access region of interest is located in the GLS ([0046] after a given skin surface image is registered with the surface frame 44, the position of all pixels in the skin surface image is known in reference to the surface frame 44).
Welch and Caluser are considered analogous because both disclose medical localization systems utilizing a grid. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to illuminate all the pixels surrounding an anatomical feature in a way that illuminates the entire structure in order to coregister images with a higher degree of accuracy (Caluser [0007]).
Regarding claim 30, Welch fails to teach light elements are light emitting diodes.
However, Caluser teaches light elements are light emitting diodes ([0048] light sources 86, such as, for example laser emitting LEDS)
Welch and Caluser are considered analogous because both disclose medical localization systems utilizing a grid. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to design the grid with LEDs in order to coregister images with a higher degree of accuracy (Caluser [0007]).
Claim(s) 2, 3, 6, 11, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Welch in view of Caluser as applied to claims 1 and 25 above, and further in view of Palma (US 20160310215 A1).
Regarding claim 2, Welch fails to teach a depth indicator configured to indicate the depth of the anatomical site of interest.
However, Palma teaches a depth indicator configured to indicate the depth of the anatomical site of interest ([0004] identifying the coordinates of the target, including the depth the tool is to be inserted).
Welch and Palma are considered analogous because both disclose localization systems utilizing grids. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the current invention to determine the depth of the target anatomy in order to know how deep to insert a tool (Palma [0004]).
Regarding claim 3, Welch fails to teach a screen configured to indicate the depth of the anatomical site of interest.
However, Palma teaches a screen configured to indicate the depth of the anatomical site of interest ([0067] a user may locate the lesion 720 on a display screen).
Welch and Palma are considered analogous because both disclose localization systems utilizing grids. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the current invention to display the location of the target anatomy including depth on a screen in order to know how deep to insert a tool (Palma [0004]).
Regarding claim 6, Welch fails to teach the imaging unit is an x-ray imaging unit, ultrasound imaging unit, magnetic-resonance imaging (MRI) unit, computed tomography (CT) imaging unit, positron-emission tomography (PET) imaging unit, or PET-CT imaging unit.
However, Palma teaches the imaging unit is an x-ray imaging unit, ultrasound imaging unit, magnetic-resonance imaging (MRI) unit, computed tomography (CT) imaging unit, positron-emission tomography (PET) imaging unit, or PET-CT imaging unit ([0012] x-ray source and an x-ray detector).
Welch and Palma are considered analogous because both disclose localization systems utilizing grids. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the current invention to image the target anatomy with an x-ray in order to know how deep to insert a tool (Palma [0004]).
Regarding claim 11, Welch fails to teach the processor is in communication with the GLS via a wired connection or wireless connection.
However, Palma teaches a processor ([0060] In at least one embodiment, a controller is used to correlate the marker with the target or lesion 420. The controller may be in the form of a computer or processor having a memory and imaging processing capabilities).
While Palma does not disclose the manner in which the communication is performed, a wired connection or a wireless connection comprises all forms of connection and thus the connection in Palma will inherently either be wired or wireless.
Welch and Palma are considered analogous because both disclose localization systems utilizing grids. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the current invention to control the functionality of the device with a processor in order to know how deep to insert a tool (Palma [0004]).
Regarding claim 28, Welch fails to teach the imaging unit is an x-ray imaging unit, ultrasound imaging unit, magnetic-resonance imaging (MRI) unit, computed tomography (CT) imaging unit, positron-emission tomography (PET) imaging unit, or PET-CT imaging unit.
However, Palma teaches the imaging unit is an x-ray imaging unit, ultrasound imaging unit, magnetic-resonance imaging (MRI) unit, computed tomography (CT) imaging unit, positron-emission tomography (PET) imaging unit, or PET-CT imaging unit ([0012] x-ray source and an x-ray detector).
Welch and Palma are considered analogous because both disclose localization systems utilizing grids. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the current invention to image the target anatomy with an x-ray in order to know how deep to insert a tool (Palma [0004]).
Response to Arguments
Applicant’s arguments, see pages 8-10, filed 1/6/2026, with respect to the rejection(s) of the independent claims under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the newly cited Caluser reference.
Applicant argues persuasively that the newly amended limitations regarding the light elements in the grid localization system are not reasonably taught by the previous prior art combination. However, an updated search has uncovered the newly cited Caluser reference which teaches an LED based grid localization system analogous to the one claimed in the pending application and depicted in fig. 6 of the Caluser reference. For at least the aforementioned reasons, the claim set remains rejected under 35 USC 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GABRIEL VICTOR POPESCU/Examiner, Art Unit 3797 /SERKAN AKAR/Primary Examiner, Art Unit 3797